It was reported that the patient was scheduled for a full revision.
It was reported that since the time of the patient¿s battery replacement in (b)(6) 2017, the patient has complained of intermittent shocking pain that travels from his armpit area up to his lateral left neck and only occurs when the vns is on.
The device was turned off and the events stopped.
X-rays were stated to show nothing.
The patient underwent a full replacement.
The surgeon state that the lead insulation near the generator was no longer present, causing the wires to be exposed.
This was the area the patient was feeling the shocking sensations.
System diagnostics were performed before surgery and impedance was ok.
The generator was on prior to the surgery staring.
It was stated he was on rapid cycling according to the surgeon¿s notes.
However it was stated he was in patient for an emu stay at some point in the last 24 hours and his settings were changed.
The explanted generator and lead were received for analysis.
Analysis is underway but has not been completed to date.
No additional or relevant information has been received to date.